JP6235008B2 - Stapling apparatus and staple cartridge assembly - Google Patents
Stapling apparatus and staple cartridge assembly Download PDFInfo
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- JP6235008B2 JP6235008B2 JP2015520660A JP2015520660A JP6235008B2 JP 6235008 B2 JP6235008 B2 JP 6235008B2 JP 2015520660 A JP2015520660 A JP 2015520660A JP 2015520660 A JP2015520660 A JP 2015520660A JP 6235008 B2 JP6235008 B2 JP 6235008B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07292—Reinforcements for staple line, e.g. pledgets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B17/1155—Circular staplers comprising a plurality of staples
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00539—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated hydraulically
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00876—Material properties magnetic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B2017/07214—Stapler heads
- A61B2017/07271—Stapler heads characterised by its cartridge
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
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Description
本発明は、概してステープリング装置の分野に関し、具体的には、体腔内の組織の内視鏡下ステープリング（ｅｎｄｏｓｃｏｐｉｃ ｓｔａｐｌｉｎｇ）に用いることができる装置に関する。 The present invention relates generally to the field of stapling devices, and in particular to devices that can be used for endoscopic stapling of tissue within a body cavity.
肥満および肥満糖尿病（ｏｂｅｓｉｔｙ−ｒｅｌａｔｅｄ ｄｉａｂｅｔｅｓ）の治療のための標準的な処置は、外科的に、または胃内においてステープル留めされた折り畳み部（ｆｏｌｄｓ）または組織皺襞（ｔｉｓｓｕｅ ｐｌｉｃａｔｉｏｎｓ）を形成することによって、胃容積を縮小することである。所有者共通の（ｃｏ−ｏｗｎｅｄ）米国特許第８，０２０，７４１号（特許文献１）、同第７，９２２，０６２号（特許文献２）、同第７，９１３，８９２号（特許文献３）、同第７，９０９，２２３号（特許文献４）、同第７，９０９，２２２号（特許文献５）、同第７，９０９，２１９号（特許文献６）および同第７，７０８，８２１号（特許文献７）は、例えば、口腔から患者の胃に挿入され、胃の一部を引っ張って折り畳み部を形成し、その折り畳み部をステープルの円形アレイによってステープル留めして、胃内に組織皺襞を形成するように操作される内視鏡下ステープリング装置を開示している。理想的には、総胃容積を十分に、例えば元の容積の半分未満に、縮小するためには、複数の、典型的には約８〜１５本の、そのような皺襞を生成する必要がある。これは、毎回皺襞を形成した後にステープリング装置を胃から抜去し、新たなステープルのアレイを再装填して、再び患者の胃に導入し、次いで新たな皺襞を形成するために操作することを必要とする。よって、１０箇所のそのような皺襞を必要とする胃縮小術では、医師が全処置中にステープリング装置を合計１０回挿入および抜去することを必要とする。これは、多くの時間を要するとともに患者も不快であり、装置が胃に挿入される最中に患者の胃を傷つける危険性を増大する。 Standard treatments for the treatment of obesity and obesity-related diabetes are surgically or by forming folds or tissue applications that are stapled in the stomach. To reduce the stomach volume. U.S. Patent Nos. 8,020,741 (Patent Document 1), 7,922,062 (Patent Document 2), and 7,913,892 (Patent Document 3) ), 7,909,223 (Patent Document 4), 7,909,222 (Patent Document 5), 7,909,219 (Patent Document 6), and 7,708, No. 821 (Patent Document 7) is inserted into a patient's stomach from the oral cavity, for example, and a part of the stomach is pulled to form a fold, and the fold is stapled by a circular array of staples. An endoscopic stapling device that is operated to form a tissue fold is disclosed. Ideally, in order to reduce the total stomach volume sufficiently, e.g., to less than half of the original volume, it is necessary to generate multiple, typically about 8-15, such folds. is there. This means that after each fold is formed, the stapling device is removed from the stomach, reloaded with a new array of staples, reintroduced into the patient's stomach, and then manipulated to form a new fold. I need. Thus, gastric reduction requiring 10 such folds requires the physician to insert and remove the stapling device a total of 10 times during the entire procedure. This is time consuming and uncomfortable for the patient, increasing the risk of damaging the patient's stomach while the device is inserted into the stomach.
従って、連続した皺襞形成の間に再装填する（ｒｅｌｏａｄ）必要のない、複数のステープル留めされた組織皺襞を生成するために医師によって用いられるステープラー装置を提供することが望ましい。 Accordingly, it would be desirable to provide a stapler device that can be used by a physician to produce a plurality of stapled tissue folds that do not need to be reloaded between successive plications.
本発明は一態様において、再装填する必要のない、複数のステープル留めされた組織皺襞を生成する際に用いられるステープリング装置を包含する。この装置は、動作状態において、ステープルカートリッジアセンブリを保持するための内部に取り付けられたカートリッジアセンブリ支持体を有するステープルハウジングと、前記支持体上に保持され、かつ、偏倚したステープルスロットの複数の群と、前記スロット内に保持されたステープルとを有するカートリッジを備えたカートリッジアセンブリであって、各群中のスロットはカートリッジアセンブリ中心軸線のまわりに円形に配列され、前記軸線に関して外側に向かって配向されている、カートリッジアセンブリと、後退位置と伸長位置との間を移動するようにハウジングに取り付けられたステープル駆動体とから構成されたステープラーヘッドを備える。前記駆動体は、前記カートリッジ内において第１ステープル群のステープルと係合し、プッシャ駆動体が後退位置から伸長位置に向かって移動すると、前記カートリッジからステープルを射出するための複数のプッシャアームを有するプッシャを備える。ステープルハウジング内の割り出し機構（ｉｎｄｅｘｉｎｇ ｍｅｃｈａｎｉｓｍ）は、前の群のステープルがカートリッジから射出された後に、ステープルカートリッジをステープルプッシャに対して前進させて、前記カートリッジ内の次の番のステープル群を前記プッシャ内の関連するアームと係合させるように配置する。前記装置内のステープルハウジングおよびアンビルハウジングは、前記ハウジングのうちの一方におけるハウジング駆動体の制御下において、ステープル留め位置に向かって、およびステープル留め位置にから離れて、互いに対して相対的に移動するように取り付けられている。前記ステープル留め位置において、２つの前記ハウジングの間に配置された組織折り畳み部は、前記カートリッジアセンブリと前記アンビルハウジング内のアンビルとの間におけるステープル留めのために捕捉される。前記カートリッジアセンブリとアンビルとの間に捕捉された組織折り畳み部を、前記カートリッジアセンブリ内の連続した偏倚ステープル群からのステープルによって、連続的にステープル留めすることにより、前記装置を再装填することなく、連続したステープル留めされた組織折り畳み部を形成することができる。前記ステープルカートリッジは、前記支持体に対して解放可能に取り付けられる。 The present invention, in one aspect, includes a stapling device used in generating a plurality of stapled tissue folds that need not be reloaded. The apparatus includes a staple housing having an internally mounted cartridge assembly support for holding a staple cartridge assembly in an operating state, and a plurality of groups of staple slots held and biased on the support. A cartridge assembly having a cartridge having staples held in the slots, wherein the slots in each group are arranged in a circle around a central axis of the cartridge assembly and oriented outwardly with respect to the axis. A stapler assembly comprised of a cartridge assembly and a staple driver attached to the housing for movement between a retracted position and an extended position. The drive body engages with the staples of the first staple group in the cartridge, and has a plurality of pusher arms for ejecting the staples from the cartridge when the pusher drive body moves from the retracted position toward the extended position. Provide a pusher. An indexing mechanism in the staple housing advances the staple cartridge relative to the staple pusher after the previous group of staples has been ejected from the cartridge, and moves the next number of staples in the cartridge to the pusher. It is arranged to engage with the associated arm within. A staple housing and an anvil housing within the apparatus move relative to each other toward and away from the stapling position under control of a housing driver in one of the housings. It is attached as follows. In the stapling position, a tissue fold disposed between the two housings is captured for stapling between the cartridge assembly and an anvil in the anvil housing. By continuously stapling the tissue fold captured between the cartridge assembly and the anvil with staples from successive biased staple groups in the cartridge assembly, without reloading the device. A continuous stapled tissue fold can be formed. The staple cartridge is releasably attached to the support.
一実施形態において、前記アセンブリ内のカートリッジは外面を有し、前記カートリッジ内のステープルは各々前記カートリッジの外側面から突出する一対の自由端を有し、前記カートリッジアセンブリは、前記カートリッジの外側面に対して積層された複数の補強リングを備え、各リングは、各ステープル群に対して１つのリングがカートリッジアセンブリに積層されるように、所与のステープル群中のステープルの自由端の一方または双方を内部に受容するための複数の円形に配列にされた穴（ｅｙｅｌｅｔｓ）を有し、前記ステープル群は外側から内側の方向に積層されたリングの順序で射出される。 In one embodiment, the cartridge in the assembly has an outer surface, the staples in the cartridge each have a pair of free ends protruding from the outer surface of the cartridge, and the cartridge assembly is on the outer surface of the cartridge. A plurality of reinforcing rings stacked against each other, one or both of the free ends of the staples in a given group of staples, such that one ring is stacked on the cartridge assembly for each group of staples. The staples are fired in the order of the rings stacked from the outside to the inside, with a plurality of circularly arranged holes for receiving the inside.
前記カートリッジはそれぞれＭ個のスロットのＮ個の群を備え、ここで、ＮおよびＭはそれぞれ少なくとも３であり、かつ、Ｎ×Ｍは少なくとも１２である。
前記プッシャアームは、前記ステープルがステープル射出動作中に受容される谷部を提供し、谷部はステープルを谷部の中心に案内するための丸味を帯びた側面を有する。
Each cartridge comprises N groups of M slots, where N and M are each at least 3 and N × M is at least 12.
The pusher arm provides a trough where the staple is received during a staple firing operation, the trough having a rounded side for guiding the staple to the center of the trough.
一実施形態において、前記カートリッジは支持体に対して角度方向に移動するようにカートリッジアセンブリ支持体に取り付けられ、割り出し機構は、前のステープル群中のステープルが射出された場合に、前記プッシャがその後退位置に向かって移動されるにつれて、前記カートリッジを次の番の割り出し位置へ前進させるために、前記支持体とカートリッジとの間に作動可能に挟持されたトーションばねを備える。割り出し機構は、プッシャアームの少なくとも１つの上に、前記プッシャがその後退位置に向かって移動されるにつれて、前記カートリッジ内の次の番のステープラー群中のステープルの少なくとも１つと係合するタブをさらに備える。 In one embodiment, the cartridge is attached to a cartridge assembly support so as to move in an angular direction relative to the support, and an indexing mechanism is provided so that when the staple in the previous staple group is fired, the pusher A torsion spring operatively sandwiched between the support and the cartridge is provided to advance the cartridge to the next indexing position as it is moved toward the retracted position. The indexing mechanism further includes a tab on at least one of the pusher arms that engages at least one of the staples in the next number of staplers in the cartridge as the pusher is moved toward its retracted position. Prepare.
別の実施形態において、前記カートリッジアセンブリは定位置でカートリッジホルダに取り付けられ、割り出し機構は、前のステープル群中のステープルが射出された場合に、前記プッシャがその後退位置に向かって移動されるにつれて、プッシャアームを前記カートリッジ内において次の番の割り出し位置へ前進させるために、前記カートリッジとステープラー駆動体との間に作動可能に挟持されたトーションばねを備える。割り出し機構は、プッシャアームの少なくとも１つの上に、プッシャがその後退位置に向かって移動されるにつれて前記カートリッジアセンブリ上の次の番のスロットと係合するタブをさらに備える。 In another embodiment, the cartridge assembly is attached to the cartridge holder in place and the indexing mechanism is moved as the pusher is moved toward its retracted position when staples in a previous group of staples are fired. And a torsion spring operably sandwiched between the cartridge and a stapler drive body for advancing the pusher arm to the next index position within the cartridge. The indexing mechanism further comprises a tab on at least one of the pusher arms that engages with the next slot on the cartridge assembly as the pusher is moved toward its retracted position.
ステープルカートリッジは円筒状マガジンであってもよく、円筒状マガジンの偏倚したステープルスロットの複数の群は、カートリッジアセンブリを通って延び、かつ、その内部にステープルを保つためにスロットの底でテーパーをなす。前記カートリッジ内に形成されたスロットは、該カートリッジの中心軸から突出する半径に沿って延びる。これに代わって、前記カートリッジ内に形成されたスロットは、スロットの内端と交差する半径方向の線が第２スロットとその内端と外端との間において交差するように、互いから半径方向に偏倚されていてもよい。 The staple cartridge may be a cylindrical magazine, and the groups of biased staple slots in the cylindrical magazine extend through the cartridge assembly and taper at the bottom of the slot to hold the staples therein. . A slot formed in the cartridge extends along a radius protruding from the central axis of the cartridge. Alternatively, the slots formed in the cartridge are arranged radially from each other such that a radial line intersecting the inner end of the slot intersects between the second slot and its inner and outer ends. May be biased.
前記カートリッジに搭載されたステープルはＵ字型であってもよく、ステープル脚部は、ステープルの基部に向かって進むにつれて内側にテーパーをなし、かつ、ステープルの自由端に向かって進むにつれて内側にテーパーをなすように、外側に向かって弓状に湾曲（ｂｏｗｅｄ）している。 The staples mounted on the cartridge may be U-shaped, and the staple legs taper inwardly as they proceed toward the staple base and taper inwardly as they proceed toward the free end of the staple. It is bowed toward the outside so as to form a circle.
アンビルは、複数のアンビル表面を、群中の各ステープルに一つずつ備えてもよく、各表面は、ステープルの両端部が並置されて重なった形態に折り曲げられるように、アンビルに対して射出されているステープルを折り曲げるための一対の並置された溝を備える。 The anvil may include a plurality of anvil surfaces, one for each staple in the group, each surface being ejected against the anvil such that both ends of the staple are folded side by side and overlapped. A pair of juxtaposed grooves for folding the staples being laid.
ステープルハウジングおよびアンビルハウジングは、前記装置内において、互いに向かって、および互いから離れて移動するように、アームアセンブリによって取り付けられる。ハウジング駆動体は、その後退位置から伸長位置に向かう移動が、アームアセンブリを外側に広げさせて、アンビルハウジングをステープルハウジングに向けて相対的に移動させるように、ステープルハウジングをアームアセンブリに作動可能に接続する。アームアセンブリは少なくとも一対のアームを備えてもよく、アームの各々は、アンビルハウジングがステープルハウジングに向かって相対的に引き寄せられるにつれて外側に旋回し、アームは、ステープルカートリッジアセンブリおよびアンビルの対向面と共に、２つのハウジングが互いに向かって引き寄せられるにつれて外側に拡張する組織チャンバを形成する。装置は組織チャンバを被覆する膜をさらに備えてもよく、膜への真空の適用により、組織が組織チャンバ内に引き込まれることを可能にする。装置は、ステープルハウジングがアンビルハウジングに向かって相対的に移動するにつれて、アームアセンブリを外側に広げるために、ステープルホルダをアームアセンブリに枢軸的に接続する少なくとも１つのアームスプレッダーをさらに備える。アンビルハウジングは、ステープルハウジングがアンビルハウジングに向かって相対的に移動するにつれて、アンビルハウジング内のアンビルをステープルハウジングに向かって前進させるために、アームアセンブリをアンビルに作動可能に接続する駆動リンクをさらに備える。 The staple housing and the anvil housing are attached by the arm assembly to move toward and away from each other within the device. The housing driver is operable to move the staple housing to the arm assembly such that movement from its retracted position to the extended position causes the arm assembly to expand outward and move the anvil housing relative to the staple housing. Connecting. The arm assembly may comprise at least a pair of arms, each of the arms pivoting outward as the anvil housing is pulled relatively toward the staple housing, the arms together with opposing surfaces of the staple cartridge assembly and the anvil, A tissue chamber is formed that expands outward as the two housings are pulled toward each other. The device may further comprise a membrane covering the tissue chamber, allowing application of a vacuum to the membrane to allow tissue to be drawn into the tissue chamber. The apparatus further comprises at least one arm spreader that pivotally connects the staple holder to the arm assembly to spread the arm assembly outward as the staple housing moves relative to the anvil housing. The anvil housing further comprises a drive link operably connecting the arm assembly to the anvil to advance the anvil in the anvil housing toward the staple housing as the staple housing moves relative to the anvil housing. .
患者の胃内において複数のステープル留めされた組織皺襞を形成するのに用いるために、前記装置は、ステープルハウジングに作動可能に接続された先端部と、使用者操縦装置（ｕｓｅｒ ｃｏｎｔｒｏｌｓ）を有する基端部とを有する長尺状可撓性シャフトと、選択された使用者操縦装置から駆動アセンブリの選択された駆動ねじ（ｄｒｉｖｅ ｓｃｒｅｗ）にトルクを伝達するためにシャフト内に搭載されたトルク伝達ケーブルとをさらに備え得る。シャフトは、選択された患者の胃領域へ口腔内アクセスするための寸法を有する。 For use in forming a plurality of stapled tissue folds in a patient's stomach, the device includes a tip operably connected to a staple housing and a user control device. An elongate flexible shaft having an end and a torque transmission cable mounted in the shaft for transmitting torque from a selected user steering device to a selected drive screw of the drive assembly And may be further provided. The shaft has dimensions for intraoral access to a selected patient's stomach region.
別の態様において、本発明は、連続した皺襞形成の間に装置を再装填する必要のない、複数のステープル留めされた組織皺襞を生成するためのステープリング装置とともに使用するためのステープルカートリッジアセンブリを包含する。このアセンブリは、（ａ）偏倚したステープルスロットの複数の群を有するステープルカートリッジであって、各群中のスロットはカートリッジ中心軸線のまわりに円形に配列され、前記軸線に関して外側に向かって配向されている、ステープルカートリッジと、（ｂ）前記スロット内に保持され、前記カートリッジの外面から延びる一対の自由端を有するステープルと、（ｃ）前記カートリッジの外面に対して積層された複数の補強リングとを備え、各リングは、各ステープル群に対して１つのリングがカートリッジアセンブリに積層されるように、所与のステープル群中のステープルの自由端を内部に受容するための複数の円形に配列にされた穴を有し、ステープル群は外側から内側の方向に積層されたリングの順序で射出される。 In another aspect, the present invention provides a staple cartridge assembly for use with a stapling device for generating a plurality of stapled tissue folds without the need to reload the device during successive fold formation. Include. The assembly is (a) a staple cartridge having a plurality of groups of biased staple slots, the slots in each group being arranged in a circle around the cartridge central axis and oriented outwardly with respect to the axis. A staple cartridge; (b) a staple having a pair of free ends held in the slot and extending from an outer surface of the cartridge; and (c) a plurality of reinforcing rings stacked against the outer surface of the cartridge. Each ring is arranged in a plurality of circles for receiving therein the free ends of the staples in a given staple group such that one ring for each staple group is laminated to the cartridge assembly. The staples are fired in the order of the rings stacked in the direction from the outside to the inside.
ステープルカートリッジは円筒状マガジンであってもよく、円筒状マガジンの偏倚したステープルスロットの複数の群は、カートリッジアセンブリを通って延び、かつ、その内部にステープルを維持するためにスロットの底でテーパーをなし、スロットは、上記のように、半径方向に突出しているか、または半径方向に偏倚していてもよい。 The staple cartridge may be a cylindrical magazine, and the plurality of groups of biased staple slots in the cylindrical magazine extend through the cartridge assembly and taper at the bottom of the slot to maintain the staples therein. None, the slots may protrude radially or be biased radially as described above.
別の態様において、本発明は、再装填する必要のない、複数のステープル留めされた組織皺襞を生成する際に用いるためのステープリング装置を包含する。この装置は、（ａ）カートリッジは複数の角度方向に偏倚した（ａｎｇｕｌａｒｌｙ ｏｆｆｓｅｔ）ステープルスロットを有し、（ｂ）ステープル駆動体は、カートリッジ内の一つのステープルに係合するための単一プッシャアームを有するプッシャを有し、よって単一のステープルでそれぞれ固定された複数の組織皺襞を形成すること以外は、上述した要素および動作を有する。 In another aspect, the present invention includes a stapling device for use in generating a plurality of stapled tissue folds that do not need to be reloaded. The apparatus includes: (a) a cartridge having a plurality of angularly offset staple slots; and (b) a staple driver for a single pusher arm for engaging a single staple in the cartridge. Except that it forms a plurality of tissue folds each secured with a single staple.
本発明の以下の詳細な説明を添付図面とともに読むと、本発明のこれらおよび他の目的および特徴がより完全に明らかになるであろう。 These and other objects and features of the invention will become more fully apparent when the following detailed description of the invention is read in conjunction with the accompanying drawings.
Ｉ．ステープリング装置およびその動作の概要
この節は、例えば、肥満または肥満糖尿病の治療、または以前の胃縮小外科処置の修復において、患者の胃内に複数の組織皺襞を形成することを意図したステープリング装置の実施形態の構成要素および操作の概要を示す。そのような装置の構造および動作の詳細および代替実施形態の構造を以下の節に示す。
I. This section describes a stapling device intended to form multiple tissue folds in the patient's stomach, for example in the treatment of obesity or obesity diabetes, or in the repair of previous gastric reduction surgery The outline | summary of the component of this embodiment and operation | movement is shown. Details of the structure and operation of such a device and the structure of an alternative embodiment are given in the following sections.
ステープラー装置は、図１において参照番号２０で示されており、ステープルハウジング２２とアンビルハウジング２４とから構成されたステープルヘッド２１を備える。２つのハウジングは、それらの対向する側部において、互いに向かって、および互いから離れて相対的に移動（ｒｅｌａｔｉｖｅ ｍｏｖｅｍｅｎｔ）するように、一対のアームアセンブリ２６によって連結されている。各アームアセンブリは、外側端部においてステープルハウジングおよびアンビルハウジングにそれぞれ枢着され、内側アーム端部において互いに枢着される一対のアーム２８，３０を備える。２つのハウジングはまた、図中においてそれらの下方の表面において、２つの部分からなる（ｔｗｏ−ｓｅｃｔｉｏｎ）拡張バー３２によって連結されている。２つのハウジングの内側に面する端部、２つのハウジングを接続するアームアセンブリ、および拡張バーの組み合わせは、透明な可撓性膜（図示せず）によって被覆される組織チャンバ３４を形成する。皺襞を生成する動作中に、２つのハウジングは互いに向けて移動して、アームアセンブリを外側に旋回させ、拡張バーを外側に屈曲させ、装置に適用された真空下で、図中の可撓性膜の上面の開口を介して組織が前記チャンバに引き込まれるにつれて、組織チャンバの幅および高さを拡張する。組織捕捉動作中における互いに向かう２つのハウジングの移動の速度およびチャンバに適用される真空率（ｒａｔｅ ｏｆ ｖａｃｕｕｍ）は、チャンバ内に生じる組織折り畳み部がチャンバの高さおよび巾寸法を実質的に満たすことができるように制御される。 The stapler device is designated by reference numeral 20 in FIG. 1 and comprises a staple head 21 composed of a staple housing 22 and an anvil housing 24. The two housings are connected by a pair of arm assemblies 26 so that they move relative to each other and away from each other on their opposite sides. Each arm assembly includes a pair of arms 28, 30 pivotally attached to the staple housing and anvil housing, respectively, at the outer end and pivotally attached to each other at the inner arm end. The two housings are also connected by a two-section expansion bar 32 at their lower surface in the figure. The combination of the inward facing ends of the two housings, the arm assembly connecting the two housings, and the expansion bar form a tissue chamber 34 that is covered by a transparent flexible membrane (not shown). During the operation of generating the scissors, the two housings move towards each other, pivoting the arm assembly outward, bending the expansion bar outward, and under the vacuum applied to the device, the flexibility in the figure As tissue is drawn into the chamber through the opening in the upper surface of the membrane, the width and height of the tissue chamber is expanded. The rate of movement of the two housings toward each other during the tissue capture operation and the rate of vacuum applied to the chamber is such that the tissue fold that occurs in the chamber substantially fills the height and width dimensions of the chamber. It is controlled to be able to.
図１および図２を参照すると、装置内のステープルカートリッジアセンブリ３６は、図５Ａおよび図５Ｂを参照して以下で詳述するように、カートリッジ支持体上においてステープルハウジング内に搭載されている。図２において最もよく分かるように、アセンブリ３６内のカートリッジ３８は、内部にステープル４２のようなステープルを受容するための、スロット４０ａ，４０ｂ，４０ｃのようなステープルスロットの円形アレイを有する円筒状マガジンである。これらのスロットはそれぞれＭ個のスロットからなるＮ個の群を形成すると見なすことができる。ここで任意の１つの群中のスロットはカートリッジのまわりに円形に配列され、他のＮ−１群中のスロットによって隔てられている。よって、例えば、カートリッジ３８内の２４個のスロットは、それぞれ３つのスロットの８つの群を形成することができ、その場合には１つの群はカートリッジにおいて２つ置きのスロット（ｅｖｅｒｙ ｔｈｉｒｄ ｓｌｏｔ）を含み、または４つのスロットの６つの群を形成することができ、その場合には１つの群はカートリッジにおいて３つ置きのスロット（ｅｖｅｒｙ ｆｏｕｒｔｈ ｓｌｏｔ）含む、等。異なる数のスロットおよびスロット形態を有するカートリッジについては、図１２Ａ〜図１２Ｄを参照しながら後述する。 With reference to FIGS. 1 and 2, the staple cartridge assembly 36 in the apparatus is mounted within the staple housing on the cartridge support, as described in detail below with reference to FIGS. 5A and 5B. As best seen in FIG. 2, the cartridge 38 in the assembly 36 has a cylindrical magazine having a circular array of staple slots, such as slots 40a, 40b, 40c, for receiving staples, such as staples 42 therein. It is. Each of these slots can be considered to form N groups of M slots. Here, the slots in any one group are arranged in a circle around the cartridge and are separated by slots in the other N-1 groups. Thus, for example, the 24 slots in the cartridge 38 can each form 8 groups of 3 slots, in which case one group has every second slot in the cartridge. Or can form six groups of four slots, where one group includes every fourth slot in the cartridge, etc. A cartridge having a different number of slots and slot configurations will be described later with reference to FIGS. 12A-12D.
図２に示したように、図５Ａおよび図５Ｂを参照して後述するステープルハウジング内のステープル駆動体は、ある群（この場合には３つのステープル群）のステープルをカートリッジからカートリッジアセンブリとアンビルハウジング２４内のアンビル４６との間に捕捉された組織折り畳み部（図示せず）を介して射出するための、アーム４４ａ，４４ｂ，４４ｃのような複数のプッシャアーム有する。カートリッジアセンブリおよびアンビルは、ステープルサイズに応じて、典型的には、それらの組織捕捉位置において約０．１５２〜０．２７９ｃｍ（約０．０６〜０．１１インチ）の距離によって互いから離間され、よって組織捕捉位置では、図２に示したよりも互いにより接近して離間されている。射出中に、ステープルは、捕捉された組織折り畳み部に押し通され、ステープルを圧着する（ｃｒｉｍｐ）ためにアンビルと接触すると、内側に折り曲げられる。ステープルがカートリッジから射出された後、割り出し機構が作動して、後述するように、カートリッジまたはプッシャアームのいずれかを前進させることにより、プッシャアームが今度はカートリッジ内の次の番のスロット群のステープルと係合するように整合される。チャンバから真空を解放すると、ステープル留めされた組織折り畳み部も解放され、装置は、新たな組織折り畳み部を捕捉してステープル留めする準備が整う。 As shown in FIG. 2, the staple driver in the staple housing, described below with reference to FIGS. 5A and 5B, moves a group (in this case, three staple groups) of staples from the cartridge to the cartridge assembly and anvil housing. A plurality of pusher arms, such as arms 44a, 44b, 44c, for ejection through a tissue fold (not shown) captured between an anvil 46 in 24. Depending on the staple size, the cartridge assembly and anvil are typically spaced from each other by a distance of about 0.06 to 0.11 inches at their tissue capture location, Thus, the tissue capture positions are more closely spaced from each other than shown in FIG. During firing, the staple is pushed inward into the captured tissue fold and folded inward upon contact with the anvil to crimp the staple. After the staples are ejected from the cartridge, the indexing mechanism is actuated to advance either the cartridge or the pusher arm, as described below, so that the pusher arm is now in the next number of slots in the cartridge. Aligned to engage. When the vacuum is released from the chamber, the stapled tissue fold is also released and the device is ready to capture and staple new tissue folds.
図２から認識されるように、図示した実施形態は、組織折り畳み部を３つの円形に配列されたステープルでステープル留めし、再装填することなく、最高８つの皺襞を生成できるように設計されている。単にプッシャ駆動体内のプッシャアームの数を変更することにより、同一の装置が、それぞれ４本のステープルによって６つの折り畳み部、それぞれ６本のステープルによって４つの折り畳み部、またはそれぞれ８本のステープルによって３つの折り畳み部を形成するように適合される。８つ、３つ、および４つの均等に配列されたステープルによる組織皺襞を図３Ａ〜図３Ｃの参照番号４８，５０，５２においてそれぞれ示す。各皺襞はまた、当初はステープルカートリッジに接触していた皺襞の側面に対して押し付けられた補強リング５４，５６，５８をそれぞれ備える。補強リングは、あるステープル群中のすべてのステープルの自由端を受容するための穴を有しており、装置におけるカートリッジアセンブリの一部を形成し、各ステープル群に対して１つのリングであり、補強リングは、図１１Ａ、図１１Ｂ、および図１４を参照して後述するように、カートリッジの外面上において、偏倚した穴を有して、互いに（ｏｎｅ ａｇａｉｎｓｔ ｔｈｅ ｏｔｈｅｒ）積み重ねられている。 As can be appreciated from FIG. 2, the illustrated embodiment is designed to generate up to eight wrinkles without stapling and reloading the tissue fold with three circularly arranged staples. Yes. By simply changing the number of pusher arms in the pusher drive, the same device would have 6 folds with 4 staples each, 4 folds with 6 staples each, or 3 with 8 staples each. Adapted to form two folds. Tissue folds with 8, 3, and 4 evenly arranged staples are shown at reference numerals 48, 50, 52 in FIGS. 3A-3C, respectively. Each kite also includes a reinforcing ring 54, 56, 58, respectively, pressed against the side of the kite that was initially in contact with the staple cartridge. The reinforcing ring has a hole for receiving the free ends of all staples in a group of staples and forms part of the cartridge assembly in the apparatus, one ring for each group of staples; The reinforcing rings are stacked one on the other with biased holes on the outer surface of the cartridge, as will be described later with reference to FIGS. 11A, 11B, and 14.
前述の装置の動作は、図５Ａおよび図５Ｂに関してさらに以下に説明されるピストンアセンブリの制御下にある。簡潔に述べると、ステープルハウジング内のピストンアセンブリは、（ｉ）ステープルハウジング内のカートリッジ支持体をアンビルに向かって先端方向に移動させ、かつ同時に、（ｉｉ）アームアセンブリを外側に移動させて、アンビルハウジングをステープルハウジングに向けて引き寄せるために、後退位置と伸長位置との間で可動な第１水力抑制ピストンを有する。ステープルハウジング内の案内スロットは、アームアセンブリの外側に向かう伸展を制限し、組織捕捉位置においてカートリッジとアンビルとの間に事前に設定された間隔を確立する。ステープル駆動体は第２水力制御ピストン上に搭載されており、第２水力制御ピストンは、組織折り畳み部が装置に捕捉されたならば、後退位置と、伸長したステープル射出位置との間においてステープル駆動体を移動させるように作動可能である。 The operation of the foregoing apparatus is under the control of a piston assembly, described further below with respect to FIGS. 5A and 5B. Briefly stated, the piston assembly in the staple housing comprises: (i) moving the cartridge support in the staple housing distally toward the anvil and simultaneously (ii) moving the arm assembly outward to A first hydraulic restraining piston movable between a retracted position and an extended position is provided for pulling the housing toward the staple housing. A guide slot in the staple housing limits extension toward the outside of the arm assembly and establishes a pre-set spacing between the cartridge and the anvil at the tissue capture position. The staple driver is mounted on the second hydraulic control piston, and the second hydraulic control piston is configured to drive the staple between the retracted position and the extended staple firing position once the tissue fold is captured by the device. Operable to move the body.
図１に示したものの説明を完了すると、装置２０は、示したように、ステープルハウジング２２に作動可能に接続された先端部と、使用者操縦装置に接続された基端部（図示せず）との間に延びる長尺状可撓性シャフト６０を備える。長尺状可撓性シャフト６０によって、操作者は胃内における装置の移動を制御し、患者の口の外側の位置から組織捕捉およびステープル留め操作を開始することができる。このシャフトは、例えば所有者共通の米国特許第８，０２０，７４１号（特許文献１）、同第７，９２２，０６２号（特許文献２）、同第７，９１３，８９２号（特許文献３）、同第７，９０９，２２３号（特許文献４）、同第７，９０９，２２２号（特許文献５）、同第７，９０９，２１９号（特許文献６）および同第７，７０８，８２１号（特許文献７）に記載されているように、真空導管、任意で圧縮流体導管の対、および装置を配置するための力伝達ケーブルを含む、様々な作動液導管（ｈｙｄｒａｕｌｉｃ−ｆｌｕｉｄ ｃｏｎｄｕｉｔｓ）およびワイヤケーブルを収容する。前記文献のすべては、参照によって本願に援用される。 Upon completion of the description of what is shown in FIG. 1, the device 20 comprises a distal end operably connected to the staple housing 22 and a proximal end (not shown) connected to the user steering device, as shown. An elongated flexible shaft 60 extending between the two. The elongate flexible shaft 60 allows the operator to control the movement of the device within the stomach and initiate tissue capture and stapling operations from a position outside the patient's mouth. For example, U.S. Pat. Nos. 8,020,741 (Patent Document 1), 7,922,062 (Patent Document 2), and 7,913,892 (Patent Document 3) common to the owners of this shaft. ), 7,909,223 (Patent Document 4), 7,909,222 (Patent Document 5), 7,909,219 (Patent Document 6), and 7,708, Various hydraulic-fluid conduits, including a vacuum conduit, optionally a pair of compressed fluid conduits, and a force transmission cable for positioning the device, as described in US Pat. No. 821 And accommodates wire cables. All of the above documents are incorporated herein by reference.
以下に述べる実施形態の説明において、装置はステープラーであり、例示的な方法は、胃組織におけるステープル留めされた皺襞の形成に関して述べられる。しかしながら、本願に記載した実施形態は、他の種類の留め具を適用するため、皺襞の形成以外の目的のためにステープルまたは他の留め具を適用するために容易に適合される特徴を含む。より具体的には、用語「ステープル」は、本願では任意の種類の留め具を示すために用いられ、そのような留め具は（ｉ）組織に押し通すことができ、（ｉｉ）アンビルに対して押し付けられたときに、組織に対して留め具を固定し、かつ、組織を固定された組織折り畳み部にまとめて保持するように、圧着される（ｃｒｉｍｐｅｄ）１つ以上の脚部材を有する。開示した実施形態および方法はまた、複数の組織折り畳み皺襞を形成することが有用である身体各部において用途が見出されるであろう。 In the description of the embodiments described below, the device is a stapler and an exemplary method is described with respect to forming stapled folds in stomach tissue. However, the embodiments described herein include features that are readily adapted to apply staples or other fasteners for purposes other than crease formation to apply other types of fasteners. More specifically, the term “staple” is used herein to denote any type of fastener, such fasteners can be (i) pushed through tissue and (ii) against an anvil. It has one or more leg members that are crimped to press the clamp against the tissue and to hold the tissue together in a fixed tissue fold when pressed. The disclosed embodiments and methods will also find use in body parts where it is useful to form multiple tissue folds.
ＩＩ．ステープラー構造
図４Ａおよび図４Ｂは、ステープルハウジング内のピストンサブアセンブリが隠されている状態（４Ａ）および示されている状態（Ｂ）の装置２０内におけるステープラーヘッド２１の斜視図である。ステープラーヘッドは、皺襞部位への挿入中には最小外形を有し、次いで、大きな内容積を有するはるかに大きな外形の装置に変形するように設計されている。例えば、一実施形態において、真空チャンバは３．２７７ｃｍ３（０．２立方インチ）の初期内容積と、９．８３２ｃｍ３（０．６立方インチ）の拡張容積（すなわち真空チャンバ内に配置されたステープラーヘッド部品によって占められる容積を引いた後の内部チャンバ容積）とを有する。この大きな内容積は、大量の組織が真空チャンバ内に引き込まれ、ステープル留めされることを可能にする。このように、ステープラーヘッドは、挿入のために侵襲性技術を必要とすることなく、比較的大きな皺襞を生成する。具体的には、皺襞は、組織に適用されたステープルがステープル留めされた組織の縁から良好に離間されるような寸法に形成することができ、ステープルの周囲の組織断裂の危険性を最小限にする。
II. Stapler Structure FIGS. 4A and 4B are perspective views of the stapler head 21 in the apparatus 20 with the piston subassembly in the staple housing hidden (4A) and shown (B). The stapler head is designed to have a minimum profile during insertion into the heel site and then deform to a much larger profile device with a large internal volume. For example, in one embodiment, the vacuum chamber is disposed within an initial internal volume of 3.277 cm 3 (0.2 cubic inches) and an expanded volume of 9.832 cm 3 (0.6 cubic inches) (ie, within the vacuum chamber). Internal chamber volume after subtracting the volume occupied by the stapler head component. This large internal volume allows a large amount of tissue to be drawn into the vacuum chamber and stapled. In this way, the stapler head produces relatively large wrinkles without requiring invasive techniques for insertion. Specifically, the wrinkles can be dimensioned such that staples applied to the tissue are well spaced from the edges of the stapled tissue, minimizing the risk of tissue tear around the staples To.
上記したように、ステープラーヘッド２１は概して、基端側ステープルハウジング２２と、先端側アンビルハウジング部材２４と、互いに向かって、および互いから離れて移動するように２つのハウジングを作動可能に接続する一対のヒンジ式アームアセンブリ（ｈｉｎｇｅｄ ａｒｍ ａｓｓｅｍｂｌｉｅｓ）２６を備える。拡張バー３２は膜持上装置として機能し、またステープルハウジング２２とアンビルハウジング２４との間に延びている。ステープルヘッドを被覆する膜は示されていないが、当然のことながら、膜は拡張バーの反対側に開口を備え、真空がチャンバに適用されると、開口を介して組織がチャンバ内に引き込まれる。 As described above, the stapler head 21 generally includes a proximal staple housing 22, a distal anvil housing member 24, and a pair that operably connects the two housings for movement toward and away from each other. Hinged arm assemblies 26. The expansion bar 32 functions as a membrane lifting device and extends between the staple housing 22 and the anvil housing 24. Although the membrane covering the staple head is not shown, it will be appreciated that the membrane has an opening on the opposite side of the expansion bar, and when vacuum is applied to the chamber, tissue is drawn into the chamber through the opening. .
ステープルハウジング２２は、ハウジングの対向する上方側部に一対のプレート６４を支持する基部６２を有し、各プレートは、２つのハウジングの移動の軸線に平行するスロット６６のような一対のスロットを有する。一対のスプレッダーアーム６８は、スロット６６内を進む（ｒｉｄｅ ｉｎ）ピン９０によって、第１駆動体ピストン（図５Ａおよび５Ｂを参照して後述）に作動可能に接続されている。スプレッダーアームは、それらの反対側の端部においてアームアセンブリ内のアーム２８に枢軸的に接続されており、その結果、駆動体ピストンのステープルハウジング内における後退位置から伸長位置への移動は、スプレッダーアームの内端部を図において上方に移動させ、アームアセンブリ２６を外側に移動させ、それによりステープルハウジングおよびアンビルハウジングを互いに向けて引き寄せる。この移動は、ピン９０がスロット６６の上端部に到達すると阻止され、装置の捕捉位置において２つのハウジング間に予め選択された間隔を画定する。 The staple housing 22 has a base 62 that supports a pair of plates 64 on opposite upper sides of the housing, each plate having a pair of slots, such as a slot 66 parallel to the axis of movement of the two housings. . The pair of spreader arms 68 are operatively connected to a first driver piston (described below with reference to FIGS. 5A and 5B) by pins 90 that advance in slots 66. The spreader arms are pivotally connected at their opposite ends to an arm 28 in the arm assembly so that movement of the drive piston from the retracted position to the extended position within the staple housing is And the arm assembly 26 is moved outward, thereby pulling the staple housing and anvil housing toward each other. This movement is prevented when the pin 90 reaches the upper end of the slot 66 and defines a preselected distance between the two housings in the capture position of the device.
図４Ｂに示すピストンアセンブリは、図５Ａおよび図５Ｂの参照番号７４において組み立て図および分解図に図示されている。これらの図に見られるように、サブアセンブリはステープルハウジングの基部に形成されたピストン型シリンダ（図示せず）内を進む第１水力制御駆動体ピストン７６を備える。ピストンはＯリング７８によってシリンダ内でシールされる。サブアセンブリ内のステープル駆動体８０は、ピストン７６によって形成された円筒空胴内を進む第２水力制御駆動体ピストン８２と、後述するように、第２ピストンがその後退位置から伸長位置に移動すると、カートリッジからステープルを射出するように機能するピストン上に搭載された複数のプッシャアーム、この実施形態では４つのプッシャアーム８４とを備える。ピストン上に取り付けられた中央ポスト８５は圧縮ばね８７を受容し、圧縮ばね８７は、以下において分かるように、ステープル留め動作後にピストンをその後退位置に戻すために、ステープル駆動体をその後退位置に向けて付勢する。ピストン８２は図５Ｂ中のＯリング８６によってピストン７６の円筒空胴内にシールされている。 The piston assembly shown in FIG. 4B is shown in an assembled view and an exploded view at reference numeral 74 in FIGS. 5A and 5B. As can be seen in these figures, the subassembly includes a first hydraulic control driver piston 76 that travels in a piston-type cylinder (not shown) formed in the base of the staple housing. The piston is sealed in the cylinder by an O-ring 78. The staple driver 80 in the subassembly includes a second hydraulic control driver piston 82 that travels in a cylindrical cavity formed by the piston 76, and, as will be described later, when the second piston moves from its retracted position to its extended position. , A plurality of pusher arms mounted on a piston that functions to eject staples from the cartridge, in this embodiment four pusher arms 84. A central post 85 mounted on the piston receives a compression spring 87 which, as will be seen below, brings the staple driver into its retracted position to return the piston to its retracted position after stapling operation. Energize towards. Piston 82 is sealed within the cylindrical cavity of piston 76 by O-ring 86 in FIG. 5B.
後退位置と伸長位置との間で移動するために第１ピストン７６上に搭載されているものは、ステープルカートリッジ３８をハウジング２２内に解放可能に支持するように作用するカートリッジ支持体８６である。図５Ｂを参照すると、支持体８６は、図中のピストンの頂部に形成された穴８８と係合する留め具（図示せず）によって第１ピストンに取り付けられている。この図を引き続き参照すると、支持体は、図５Ｂに見られるように、対向する側部においてブラケット９５を設けており、ブラケットおよびスプレッダーアームの孔を通って延びるピン７０によって、支持体の対向する側部にスプレッダーアーム６８を枢着する。上記したように、ピン９０がスロット６６の上端部に到達すると、図中において第１ピストンの上方への移動が阻止され、図４Ｂ中に見られるカートリッジおよびアンビルをそれらの組織捕捉位置に配置する。 Mounted on the first piston 76 for movement between the retracted and extended positions is a cartridge support 86 that acts to releasably support the staple cartridge 38 within the housing 22. Referring to FIG. 5B, the support 86 is attached to the first piston by a fastener (not shown) that engages a hole 88 formed in the top of the piston in the figure. With continued reference to this figure, the support is provided with brackets 95 on opposite sides, as seen in FIG. 5B, and is opposed to the support by pins 70 extending through the holes in the bracket and spreader arm. A spreader arm 68 is pivotally attached to the side. As described above, when the pin 90 reaches the upper end of the slot 66, the upward movement of the first piston is prevented in the figure, and the cartridge and anvil seen in FIG. 4B are placed in their tissue capture positions. .
引き続き図５Ｂを参照すると、支持体８６はポスト８５を受容するための中央開口９２と、プッシャアームの端部に搭載されたプッシャブレード９６を受容するための４つの周囲ブレード形開口９４とを有する。サブアセンブリにおけるプッシャアームの構造について、図６Ａおよび図６Ｂを参照しながら以下で詳述する。第２ピストンがその完全後退位置にある場合、プッシャブレードの上端部のみがこれらの支持体の開口を介して突出し、支持体上に搭載されたステープルカートリッジに対して、ブレード上端部（ｕｐｐｅｒ ｂｌａｄｅ ｅｎｄｓ）がカートリッジ内のステープル群の底部（基部）と係合するか、またはほぼ係合するように配置される。第２ピストンが起動され、その伸長位置に向かって移動し始めると、ブレードは、カートリッジから、ステープル群中のステープルを、装置内に捕捉された組織折り畳み部を介して、アンビル４６に対して射出する。ピストンの完全伸長位置において、ステープルは組織に対して圧着され、皺襞を形成するための動作を完了する。ステープル留め動作中に、ばね８７は、ピストン８２と支持体８６の下面との間で圧縮されるようになり、例えば、ピストンへの作動液圧力の解放によってピストンが解放されると、第２ピストンをその後退位置へ付勢するように作用する。 With continued reference to FIG. 5B, support 86 has a central opening 92 for receiving post 85 and four peripheral blade-shaped openings 94 for receiving pusher blades 96 mounted at the end of the pusher arm. . The structure of the pusher arm in the subassembly will be described in detail below with reference to FIGS. 6A and 6B. When the second piston is in its fully retracted position, only the upper end of the pusher blade protrudes through the openings in these supports, and the upper blade ends (upper blade ends) with respect to the staple cartridge mounted on the support. ) Are arranged to engage or substantially engage the bottom (base) of the staples in the cartridge. When the second piston is activated and begins to move toward its extended position, the blades eject the staples in the staple group from the cartridge to the anvil 46 via the tissue fold captured in the device. To do. In the fully extended position of the piston, the staple is crimped against the tissue to complete the operation to form the fold. During the stapling operation, the spring 87 becomes compressed between the piston 82 and the lower surface of the support 86, e.g. when the piston is released by releasing hydraulic fluid pressure on the piston, the second piston. Acts to urge it to its retracted position.
上述したステープル駆動体およびカートリッジ支持体は組織皺襞において４本のステープルの群を送給するために設計されているが、単にステープル駆動体上におけるプッシャアームの数および位置、および相応して支持体におけるブレードスロットの数および位置を変更するだけで、例えば３本、６本、または８本のような一群中における異なる数のステープルに適応できる。 The staple driver and cartridge support described above are designed to deliver groups of four staples in a tissue fold, but simply the number and position of pusher arms on the staple driver and corresponding support. By changing the number and position of the blade slots in the, it is possible to accommodate different numbers of staples in a group, such as 3, 6, or 8, for example.
引き続き図５Ａおよび図５Ｂを参照すると、支持体８６の上面はタブ９８のような４つのスナップインタブを有する（図８Ａも参照されたい）。このタブは、カートリッジの下方側面上に形成された下方環状隆条１００と係合して、カートリッジが支持体に対して回転することを依然として可能にしながら、カートリッジを支持体に解放可能に固定する。また図には、スリーブ１０３、スリーブに搭載されたトーションばね１０４、ねじれピン１０６およびカートリッジインサート１０８から構成された割り出しばねアセンブリ１０２が示されている。カートリッジが支持体上に配置されると、インサート１０８は、カートリッジの中心コアと係合して、カートリッジをばねアセンブリにロックする。支持体上にスナップ留めされる前に、カートリッジは、引張ばね１０４に対して、引張ばねがカートリッジをばね力の方向に圧迫するように手動で回転される。各ステープル留め動作後にカートリッジをわずかに回転させて、カートリッジを次の番のステープル群へ前進させる割り出し機構について、図８Ａおよび図８Ｂを参照しながら後述する。カートリッジ３８、カートリッジ内に保持されたステープル、およびステープル留めされた組織皺襞を強化するために用いられる補強リングを備えたカートリッジアセンブリについては、図１１〜図１５に関する後の節で説明する。 With continued reference to FIGS. 5A and 5B, the upper surface of the support 86 has four snap-in tabs, such as tabs 98 (see also FIG. 8A). This tab engages a lower annular ridge 100 formed on the lower side of the cartridge to releasably secure the cartridge to the support while still allowing the cartridge to rotate relative to the support. . Also shown is an index spring assembly 102 comprised of a sleeve 103, a torsion spring 104 mounted on the sleeve, a torsion pin 106 and a cartridge insert 108. When the cartridge is placed on the support, the insert 108 engages the central core of the cartridge to lock the cartridge to the spring assembly. Prior to being snapped onto the support, the cartridge is manually rotated relative to the tension spring 104 so that the tension spring compresses the cartridge in the direction of the spring force. An indexing mechanism for slightly rotating the cartridge after each stapling operation to advance the cartridge to the next staple group will be described later with reference to FIGS. 8A and 8B. A cartridge assembly comprising a cartridge 38, staples held within the cartridge, and a reinforcing ring used to reinforce the stapled tissue fold is described in a later section with respect to FIGS.
図６Ａおよび図６Ｂは、ステープル駆動体８０内の代表的なプッシャアーム８４を示している。旗型のアームは、下側ポスト１１０と、強度のためにその中間部において広がった上側ブレード１１２とを備える。ブレードは、その上端部に形成された細長い谷部１１４内において実質的にステープルの基部全体を支持するような長さの寸法を有する。図６Ｂに見られるように、谷部は、ステープルの基部をブレード上において完全に中心の位置（ｆｕｌｌｙ ｃｅｎｔｅｒｅｄ ｐｏｓｉｔｉｏｎ）に案内するのを支援するために、その側面においてテーパーをなしている。ブレードの縁から上方へ突出するタブ１１５は、図８Ａおよび図８Ｂを参照しながら後述するように、装置内の割り出し機構において停止具として機能する。 6A and 6B show an exemplary pusher arm 84 in the staple driver 80. FIG. The flag-shaped arm includes a lower post 110 and an upper blade 112 that expands in the middle for strength. The blade has a length dimension such that it supports substantially the entire staple base within an elongated valley 114 formed at its upper end. As seen in FIG. 6B, the valley is tapered on its sides to help guide the staple base to a fully centered position on the blade. The tab 115 protruding upward from the edge of the blade functions as a stop in the indexing mechanism in the apparatus, as will be described later with reference to FIGS. 8A and 8B.
図７Ａおよび図７Ｂは、連続したステープル留め動作を伴うピストンサブアセンブリの動作を示している。参照番号１１６において示されたこの特定の実施形態におけるカートリッジは、５つの群に分割され、それぞれが４本のステープルを有する、スロット１１８のような２０個のスロットを有する。図７Ａにおいて、カートリッジは、カートリッジ内の第１群中のステープル、例えばステープル１２０が、回転的に定位置（ｒｏｔａｔｉｏｎａｌｌｙ ｆｉｘｅｄ ｐｏｓｉｔｉｏｎ）を有するステープル駆動体内の４つのブレードと整合されるように配置されている。この図は、ステープル駆動体のその伸長ステープル留め位置への作動によって、第１群のスロットから射出されているステープルを示している。ステープルがカートリッジから射出された後、ピストンサブアセンブリ内の割り出し機構は、カートリッジを第２群の位置へ前進させ、ここで、プッシャアームブレードはカートリッジ内の第２群のスロット内のステープルと整合される。図７Ｂは、３回のそのようなステープル留め動作後のサブアセンブリの状態を示しており、ここではステープル駆動体は、ステープル駆動体が作動されるとカートリッジ内の４番目の群中のステープル、例えばステープル１２２がカートリッジから射出されるように配置される。 7A and 7B show the operation of the piston subassembly with a continuous stapling operation. The cartridge in this particular embodiment, indicated at reference numeral 116, has 20 slots, such as slot 118, divided into five groups, each having four staples. In FIG. 7A, the cartridge is positioned so that the staples in the first group in the cartridge, such as staples 120, are aligned with four blades in a staple driver that has a rotationally fixed position. Yes. This figure shows the staples being ejected from the first group of slots by actuation of the staple driver to its extended stapling position. After the staples are ejected from the cartridge, the indexing mechanism in the piston subassembly advances the cartridge to the second group position, where the pusher arm blade is aligned with the staples in the second group slot in the cartridge. The FIG. 7B shows the state of the subassembly after three such stapling operations, where the staple driver is a staple in the fourth group in the cartridge when the staple driver is activated, For example, the staple 122 is arranged to be ejected from the cartridge.
示したように、装置内の割り出し機構は、各ステープル留めサイクル後に、ステープルカートリッジをステープルプッシャに対して前進させ、カートリッジ内の次の番のステープル群をステープル駆動体内の関連するアームと係合させるために配置するように機能する。割り出し機構は、ステープル駆動体が一定の角度位置に保持された状態で、カートリッジを漸進的に（ｉｎｃｒｅｍｅｎｔａｌｌｙ）前進させるように機能してもよいし、またはカートリッジが静止位置に保持された状態で、ステープル駆動体を漸進的に前進させるように機能してもよい。第１アプローチはここで説明する実施形態に採用されたアプローチであり、例示的な実施について図８Ａおよび図８Ｂを参照しながら以下に述べる。第２アプローチは図９に示す。 As shown, the indexing mechanism in the apparatus advances the staple cartridge relative to the staple pusher after each stapling cycle and engages the next number of staples in the cartridge with the associated arm in the staple driver. Function to arrange for. The indexing mechanism may function to advance the cartridge incrementally with the staple driver held in a constant angular position, or with the cartridge held in a stationary position, It may function to progressively advance the staple driver. The first approach is the approach taken in the embodiments described herein, and an exemplary implementation is described below with reference to FIGS. 8A and 8B. The second approach is shown in FIG.
図８Ａは、図５Ａおよび図５Ｂを参照しながら上述したピストンサブアセンブリを示しているが、ここではカートリッジアセンブリを除去して示されており、アセンブリ内に２つのステープル群１２４，１２６によってのみ表わされている。図において、第１ステープル群中のステープル１２４は、支持体７２内の関連するブレード開口を介して突出するプッシャアームタブ１１５に対して、トーションばね１０４によって付勢されており、カートリッジが反時計回り方向（すなわち、ばね１０４によって圧迫される方向）にさらに回転するのを防止している。この第１ステープル群がカートリッジから射出される場合、ステープルがカートリッジ内のそれらのスロットから完全に射出されると、カートリッジは、今度は次のステープル群１２６がプッシャアームと接触するまで、ばね１０４によって反時計回り方向に圧迫される。図８Ｂにおいて認識され得るように、プッシャアームが完全に後退されると、ステープルの基部はプッシャアームタブとのみ接触する。次に、プッシャアームが次のステープル留め動作によって図において上方に移動されるにつれて、タブに係合したステープルの基部はプッシャアーム谷部１１４に着座し、この次の番のステープル群はカートリッジから射出され、カートリッジを３番目のステープル群に進むように解放する。 FIG. 8A shows the piston subassembly described above with reference to FIGS. 5A and 5B, but shown here with the cartridge assembly removed and represented only by the two staple groups 124, 126 within the assembly. It has been. In the figure, the staples 124 in the first staple group are biased by the torsion springs 104 against the pusher arm tabs 115 that project through the associated blade openings in the support 72 so that the cartridge is counterclockwise. Further rotation in the direction (ie, the direction compressed by the spring 104) is prevented. When this first staple group is ejected from the cartridge, once the staples are fully ejected from their slots in the cartridge, the cartridge is now moved by the spring 104 until the next staple group 126 contacts the pusher arm. It is squeezed counterclockwise. As can be seen in FIG. 8B, when the pusher arm is fully retracted, the staple base contacts only the pusher arm tab. Next, as the pusher arm is moved upward in the figure by the next stapling operation, the base of the staple engaged with the tab is seated in the pusher arm trough 114 and this next number of staples is ejected from the cartridge. The cartridge is released to advance to the third staple group.
動作中にカートリッジを漸進的に前進させるための他のいくつかの割り出し機構が企図される。一実施形態において、ばね１０４は、カートリッジに一定の付勢力を印加するために作動されたときに、カートリッジを漸進的な回転の方向に付勢するか、またはカートリッジを１つのステープル群のみ前進させるのに有効な短期間の力を印加するのに有効である水力要素、または磁気要素、または電磁気要素に置き換えられる。別の一般的な実施形態において、ステープルカートリッジは、ステープルが関連するスロット内に存在する場合のみにステープルハウジング内の停止部材と係合する寸法を有する複数の側面突起を有する。次に、各連続スロット内のステープルが射出され、かつ、関連する突起が無効にされる、例えば、破壊されるか、またはステープルスロットに退却させられると、カートリッジは次の番のステープル群において次の突起に進む。 Several other indexing mechanisms are contemplated for progressively advancing the cartridge during operation. In one embodiment, the spring 104 biases the cartridge in the direction of progressive rotation or advances the cartridge by only one staple group when actuated to apply a constant biasing force to the cartridge. It is replaced with a hydraulic element, or a magnetic element, or an electromagnetic element, which is effective for applying a short-term force effective for the operation. In another general embodiment, the staple cartridge has a plurality of side projections that are dimensioned to engage a stop member in the staple housing only when the staple is in the associated slot. Next, when the staples in each successive slot are fired and the associated protrusion is invalidated, eg, destroyed or retracted into the staple slot, the cartridge is next in the next number of staples. Proceed to the protrusion.
図９は、装置内のカートリッジが定位置で保持され、ステープル駆動体が漸進的に移動される割り出し機構を示している。図は、カートリッジ支持体１２６の上面と、ステープル駆動体の先端部に搭載され、かつ、３つのプッシャアーム１２９を有するプッシャアームアセンブリ１２８とを示している。アームアセンブリは、ステープル駆動体とカートリッジ支持体との間に挟持されたトーションばね（図示せず）によって、図において時計回り方向に回転するように付勢されている。カートリッジは、駆動体プッシャアームを収容するその下部領域において開放されており、スナップインタブテーブル（ｓｎａｐ−ｉｎ ｔａｂｓ ｔａｂｌｅｓ）（図示せず）によって支持体上に解放可能に取り付けられる。アームアセンブリのすぐ下方のアームアセンブリシャフトから外側に突出しているのは、支持体１２６の上面にある複数の非対称スロット１３２のうちの１つの中に存在するように形成されたピン１３０である。図に示したステープラー形態において、ピン１３０は、プッシャアーム１２９をカートリッジ内の第１ステープル群を表わす３つのスロットと整合させる第１スロット１３２内に存在する。ステープル駆動体がステープル留めのために作動されると、３つのプッシャアームは、ピン１３０がスロット１３２から持ち上げられる直前に、ピンの前の第１群のスロットと係合して、プッシャアセンブリと第１群のスロットとの間の整合を確保する。ステープルが射出され、ステープル駆動体がその後退位置へ戻った後、スロット１３２の非対称性は、プッシャアーム１２９がカートリッジスロットから脱係合する瞬間に、ステープル駆動体が漸進的に回転することを可能にし、ピン１３０を第２スロット１３２内に配置し、プッシャアームをカートリッジ内の次のステープル群と整合させる。 FIG. 9 shows an indexing mechanism in which the cartridge in the apparatus is held at a fixed position and the staple driver is gradually moved. The figure shows the top surface of the cartridge support 126 and a pusher arm assembly 128 mounted at the distal end of the staple driver and having three pusher arms 129. The arm assembly is biased to rotate clockwise in the figure by a torsion spring (not shown) sandwiched between the staple driving body and the cartridge support. The cartridge is open in its lower region that houses the driver pusher arm and is releasably mounted on the support by a snap-in tabs table (not shown). Protruding outwardly from the arm assembly shaft just below the arm assembly is a pin 130 formed to reside in one of the plurality of asymmetric slots 132 on the top surface of the support 126. In the stapler configuration shown, the pin 130 resides in a first slot 132 that aligns the pusher arm 129 with the three slots representing the first staple group in the cartridge. When the staple driver is actuated for stapling, the three pusher arms engage the first group of slots in front of the pins, just before the pins 130 are lifted from the slots 132, and the pusher assembly and the first Ensuring alignment with a group of slots. After the staple is fired and the staple driver returns to its retracted position, the asymmetry of the slot 132 allows the staple driver to rotate progressively at the moment the pusher arm 129 disengages from the cartridge slot. And the pin 130 is placed in the second slot 132 and the pusher arm is aligned with the next staple group in the cartridge.
静止したカートリッジに対してステープル駆動体を漸進的に回転させるための他の割り出し機構が企図される。例えば、ステープル駆動体シャフトの回転位置は、水力または電子パルスによって、またはトーションばねを磁気もしくは電磁気付勢力と置き換えることによって、制御される。これに代わって、ステープル駆動体シャフトは、各ステープル留め動作後に、それがその完全後退位置に戻ると、ステープルハウジング内の静止要素と相互に作用してステープル駆動体を漸進的に回転させるカム要素（ｃａｍｍｅｄ ｅｌｅｍｅｎｔ）を有してもよい。 Other indexing mechanisms for progressively rotating the staple driver relative to the stationary cartridge are contemplated. For example, the rotational position of the staple driver shaft is controlled by hydraulic or electronic pulses, or by replacing a torsion spring with a magnetic or electromagnetic biasing force. Alternatively, the staple driver shaft is a cam element that interacts with a stationary element in the staple housing to progressively rotate the staple driver as it returns to its fully retracted position after each stapling operation. (Cammed element).
図１０は、各ステープル留めサイクルにおいて４本のステープルを射出する装置において使用するために設計されたアンビル４６の平面図であり、ステープルによって接触されるアンビル表面を示している。アンビルは４本のアーム１３４を有し、それぞれ、一対のカプセル型陥凹領域１３６を備える。この領域は、アームの中央に沿って延びる線１４０が２つの領域の反対側の端部１３８と交差し、図示したように、各陥凹領域の長軸と約１８°の角度を形成するように各アーム表面上に配列されている。各陥凹領域がステープル脚部の折り曲げ方向を案内するので、ステープル脚部がアンビルに対して押し付けられるにつれて、２本のステープル脚部は陥凹領域自体の並置形態をとり、よってステープル留め中にステープル脚部が互いに衝突して干渉するのを防止する。 FIG. 10 is a plan view of an anvil 46 designed for use in an apparatus that fires four staples in each stapling cycle, showing the anvil surface contacted by the staples. The anvil has four arms 134, each with a pair of capsule-type recessed areas 136. This region is such that a line 140 extending along the center of the arm intersects the opposite end 138 of the two regions to form an angle of approximately 18 ° with the major axis of each recessed region, as shown. Are arranged on the surface of each arm. Since each recessed area guides the folding direction of the staple legs, as the staple legs are pressed against the anvil, the two staple legs take the juxtaposed form of the recessed areas themselves and thus during stapling The staple legs are prevented from colliding with each other and interfering with each other.
ＩＩＩ．カートリッジアセンブリ
図１１〜図１５は、ステープリング装置内におけるカートリッジアセンブリ３６の詳細を示す。図１１Ａおよび図１１Ｂに見られるように、アセンブリは、複数のステープルスロット４０と、スロット内に受容されたステープル４２とを提供するカートリッジ３８と、図１４を参照しながら以下で検討するようにカートリッジの上面上に積層されるリング１３６，１３８，１４０などの複数の補強リングとを備える。
III. Cartridge Assembly FIGS. 11-15 show details of the cartridge assembly 36 within the stapling apparatus. As seen in FIGS. 11A and 11B, the assembly includes a cartridge 38 that provides a plurality of staple slots 40 and staples 42 received in the slots, and a cartridge as discussed below with reference to FIG. And a plurality of reinforcing rings such as rings 136, 138, 140 stacked on the upper surface.
カートリッジ内のスロットは、図１１Ａにおいて見られるように、カートリッジの環状胴体内において略半径方向に延びている。上記に示したように、カートリッジは、好ましくはカートリッジ本体のまわりに円形に配列されたＮ×Ｍ個のスロットを提供し、ここでＮはスロット群の数であり、Ｍは各群中のスロットの数である。図示したカートリッジは、それぞれ４つのスロットの５つの群に分割される２０個のスロットを有するが、同一のカートリッジが任意のＮ×Ｍの組み合わせの２０本のステープル、例えばそれぞれ５本のステープルの４つの群、を射出するように設計されたステープラーに適合する。スロットの対向する側面は、説明のために、断面においてわずかに内側に向かったテーパー（ｓｌｉｇｈｔ ｉｎｗａｒｄ ｔａｐｅｒ）を有しており、ステープルがそれらのスロットから容易に射出され得るように、ステープルをぴったりと、しかし強固にではなく、保持するような寸法を有する。上述したように、カートリッジの下端部上に形成された環状隆条１００は、カートリッジをカートリッジ支持体７２に回転自在に取り付けるために用いられる。カートリッジは典型的には単一片のプラスチック製品として形成され、１〜１．５ｃｍの典型的な直径と、０．３〜１ｃｍの高さ寸法とを有する。 The slots in the cartridge extend generally radially within the annular body of the cartridge, as seen in FIG. 11A. As indicated above, the cartridge preferably provides N × M slots arranged in a circle around the cartridge body, where N is the number of slots and M is the slot in each group. Is the number of The illustrated cartridge has 20 slots, each divided into 5 groups of 4 slots, but the same cartridge has 20 staples in any N × M combination, for example 4 of 5 staples each. Fits a stapler designed to fire two groups. The opposing sides of the slots have, for illustrative purposes, a slightly inward taper in cross section so that the staples can be snug so that the staples can be easily ejected from those slots. However, it is not strong but has dimensions to hold. As described above, the annular ridge 100 formed on the lower end portion of the cartridge is used for rotatably mounting the cartridge to the cartridge support 72. The cartridge is typically formed as a single piece of plastic product and has a typical diameter of 1-1.5 cm and a height dimension of 0.3-1 cm.
図１２Ａ〜図１２Ｄは、本発明のカートリッジ内における異なる数および配列のスロットを示す平面図である。図１２Ａおよび図１２Ｂは、それぞれ、厳密に半径方向に配向された２４個および１６個のスロットを示している。図１２Ｃおよび図１２Ｄは、それぞれ、半径方向に偏倚された方向に配向された２４個および１６個のスロットの配列を示している。後者の形態は、スロットの半径方向の大きさを短縮し、必要に応じて、より広幅のステープルを可能にする。 12A-12D are plan views showing different numbers and arrangements of slots within the cartridge of the present invention. FIGS. 12A and 12B show 24 and 16 slots, which are strictly radially oriented, respectively. 12C and 12D show an array of 24 and 16 slots oriented in a radially biased direction, respectively. The latter configuration reduces the radial size of the slot and allows wider staples as needed.
カートリッジに使用される例示的なステープル４２は、図１３に示されており、基部１４２と、斜切ステープル端部または先端１４６で終了する一対の弓状に湾曲したステープル脚部１４４とを備える。ステープル脚部における弓形は、地点１４８から脚部に沿ってステープル基部に向かって進行するとわずかにテーパーをなし、断面におけるカートリッジスロットのわずかなテーパーと一致して、図８Ａおよび図８Ｂを参照して上述したように、スロット内のステープルを、ステープルの基部をステープルプッシャとの所望の相互作用のためにカートリッジ内において配置する所望の垂直位置で、支持する。ステープル端部は、鋭利な先端を提供するだけでなく、ステープルがアンビルに対して射出されたときにステープル脚部の端部を互いに向けて圧迫するために、図１３において内側から外側の方向に斜めに切断されている。 An exemplary staple 42 used in the cartridge is shown in FIG. 13 and comprises a base 142 and a pair of arcuately curved staple legs 144 that terminate at a beveled staple end or tip 146. The arc at the staple leg tapers slightly as it progresses from point 148 along the leg toward the staple base, matching the slight taper of the cartridge slot in cross-section, see FIGS. 8A and 8B. As described above, the staples in the slots are supported in a desired vertical position where the base of the staples is positioned within the cartridge for the desired interaction with the staple pusher. The staple ends not only provide a sharp tip, but also from the inside to the outside in FIG. 13 to squeeze the ends of the staple legs toward each other when the staples are fired against the anvil. It is cut diagonally.
カートリッジアセンブリ内の例示的な補強リングは図１４において参照番号１３６で示されている。リングは、スポーク１４２によって接続された内側リング部材および外側リング部材１３８，１４０のそれぞれと、完全に組み立てられた状態において関連するステープル４２の端部を受容する内側穴および外側穴１４４，１４６のそれぞれとを備える。図１１Ｂにおいて見られるように、ステープル４２が各々のスロットに装填された後、補強リングは、連続したリングのそれぞれの穴が、上下方向において、それぞれの連続した群中のステープル内のステープル端部を受容した状態で、第１群（一番上のリング）から始まって、次に２番目のリング（一番上から２番目のリング）などのように、アセンブリ上に積層される。よって、そのようなステープルの各群が射出されるとき、群は、ステープル留め中の組織折り畳み部に対して、最上位のリングを保持する。ステープルの基部がリングと係合し、そのリングをステープル留め中の組織折り畳み部に対して押し付ける直前の、ステープル留め中のステープルとリングとの相対位置を図１４Ｂに示す。ここに示したリングは、図１５Ｄを参照しながら後述する２セクションリングである。 An exemplary reinforcement ring within the cartridge assembly is indicated by reference numeral 136 in FIG. The rings are respectively inner and outer holes 144, 146 that receive the ends of the associated staple 42 in the fully assembled state with each of the inner and outer ring members 138, 140 connected by spokes 142. With. As can be seen in FIG. 11B, after the staples 42 are loaded into each slot, the reinforcing ring has a respective end of the continuous ring in the up and down direction, and the staple ends within the staples in each successive group. With the first ring (the top ring) and then the second ring (the second ring from the top) and so on. Thus, as each such group of staples is fired, the group holds the top ring against the tissue fold during stapling. The relative position of the staple and the ring during stapling just before the staple base engages the ring and presses the ring against the tissue fold during stapling is shown in FIG. 14B. The ring shown here is a two-section ring described later with reference to FIG. 15D.
カートリッジアセンブリにおける補強リングの様々な代替形態は、図１５Ａ〜図１５Ｄに示されている。図１５Ａにおいて参照番号１５０で示すリングは、穴１５６において外側リングに結合する４本の横材１５４を有する外側リング部材１５２を備え、穴１５６はステープルの外側脚部のみを受容する。図１５Ｂに示すリング１５８は、外側リング部材１６０と、穴１６４において外側リング部材に結合された４本の半径方向脚部１６２とを備え、穴１５６はステープルの外側脚部のみを受容する類似構造を有する。図１５Ｃのリング１６６は、ステープルの両端を受容する内側穴１７４および外側穴１７５を備えたクロスバー１７２によって結合された内側リング部材および外側リング部材１６６，１６８をそれぞれ有する。図１５Ｄに示すリング１７６は、ステープルの外端部および内端部を受容するための独立した穴１８２，１８４をそれぞれ備えた２つの独立したリング部材１７８，１８０を有する。２つのリング部材は、ステープルが適所にあるとすれば、カートリッジ上において独立したアセンブリを必要とする。 Various alternative forms of reinforcing rings in the cartridge assembly are shown in FIGS. 15A-15D. The ring designated by reference numeral 150 in FIG. 15A includes an outer ring member 152 having four cross members 154 that couple to the outer ring at holes 156, which receive only the outer legs of the staples. The ring 158 shown in FIG. 15B includes an outer ring member 160 and four radial legs 162 coupled to the outer ring member at holes 164, with holes 156 having a similar structure that accepts only the outer legs of the staples. Have The ring 166 of FIG. 15C has an inner ring member and an outer ring member 166, 168, respectively, joined by a cross bar 172 with an inner hole 174 and an outer hole 175 that receive both ends of the staple. The ring 176 shown in FIG. 15D has two independent ring members 178, 180 with independent holes 182 and 184, respectively, for receiving the outer and inner ends of the staple. The two ring members require a separate assembly on the cartridge if the staples are in place.
ここには示さないが、カートリッジアセンブリは、ステープルが取り付けられている易壊性ポリマーウェビング（ｗｅｂｂｉｎｇ）またはフィルムによってステープルの円形アレイが適所に保持されている単純化された構造を有してもよい。この実施形態において、ウェビングまたはフィルムはカートリッジとして機能し、カートリッジからのステープル群の射出は、それらのステープルを構造から分離するように作用する。 Although not shown here, the cartridge assembly may have a simplified structure in which a circular array of staples is held in place by a frangible polymer webbing or film to which the staples are attached. . In this embodiment, the webbing or film functions as a cartridge and ejection of staples from the cartridge acts to separate the staples from the structure.
本発明の様々な目的および特徴をどのように達成するかは上記から認識され得る。ステープリング装置は、新規のカートリッジアセンブリが装填されると、患者の胃に挿入され、２〜８本のステープルによって、任意でそれぞれ補強リングによって強化された、複数の組織皺襞が形成される。所与の数を超える皺襞、例えば９本以上の皺襞が必要とされる場合には、装置を抜去して、装置に新規のカートリッジアセンブリを迅速に再装填することができるが、いかなる場合でも、操作中における単一のカートリッジ再装填は、ほとんどいかなる胃縮小または再建手術を達成するために十分であるはずである。 It can be appreciated from the above how to achieve the various objects and features of the invention. The stapling device, when loaded with a new cartridge assembly, is inserted into the patient's stomach and a plurality of tissue folds are formed, with 2-8 staples, each optionally reinforced by a reinforcing ring. If more than a given number of kites are required, for example nine or more kites, the device can be removed and the device can be quickly reloaded with a new cartridge assembly. A single cartridge reload during operation should be sufficient to achieve almost any gastric reduction or reconstruction surgery.
優先権の目的のために信頼できるものを含む上記で言及された全ての特許、特許出願、および印刷された刊行物は、参照によって本願に援用される。 All patents, patent applications, and printed publications referred to above, including those that are reliable for priority purposes, are hereby incorporated by reference.
Claims (23)
（ａ）内部に取り付けられたカートリッジアセンブリ支持体を有するステープルハウジングと、
（ｂ）前記支持体上に保持され、かつ、偏倚したステープルスロットの複数の群を有するカートリッジと、前記スロット内に保持されたステープルとを備えたカートリッジアセンブリであって、各群中のスロットはカートリッジアセンブリの中心軸線のまわりに円形に配列されており、かつ、前記軸線に関して外側に向かって配向されている、カートリッジアセンブリと、
（ｃ）後退位置と伸長位置との間を移動するように前記ハウジングに取り付けられたステープル駆動体であって、前記カートリッジ内の第１ステープル群のステープルに係合し、後退位置から伸長位置に向かって移動すると、前記カートリッジからステープルを射出するための複数のプッシャアームを有するプッシャを備える、ステープル駆動体と、
（ｄ）前の群のステープルが前記カートリッジから射出された後に、該カートリッジを前記プッシャに対して前進させて、前記カートリッジ内の次の番のステープル群を、該プッシャ内の関連するプッシャアームと係合させるように配置する、前記ステープルハウジング内に位置する割り出し機構と、
（ｅ）アンビルを有するアンビルハウジングと、を備え、前記ステープルハウジングおよびアンビルハウジングは、前記ハウジングのうちの一方におけるハウジング駆動体の制御下において、ステープル留め位置に向かって、およびステープル留め位置から離れて、互いに関して相対的に移動するように取り付けられており、前記ステープル留め位置において、２つの前記ハウジング間に配置された組織折り畳み部は、前記カートリッジアセンブリとアンビルとの間におけるステープル留めのために捕捉され、
前記カートリッジアセンブリとアンビルとの間に捕捉された組織折り畳み部を、前記カートリッジアセンブリ内の連続した偏倚ステープル群からのステープルによって連続的にステープル留めすることによって、前記装置を再装填することなく、連続したステープル留めされた組織折り畳み部を形成することができ、
前記カートリッジは円筒状マガジンであり、前記円筒状マガジンの偏倚したステープルスロットの複数の群は、前記カートリッジアセンブリを通って延び、かつ、その内部に前記ステープルを保つために前記スロットの底でテーパーをなす、装置。 A stapling device used to generate a plurality of stapled tissue folds without having to reload the device between successive plications, wherein the device is in an operating state,
(A) a staple housing having a cartridge assembly support mounted therein;
(B) a cartridge assembly comprising a cartridge having a plurality of groups of staple slots biased and held on the support, and a staple held in the slots, wherein the slots in each group are A cartridge assembly arranged in a circle around a central axis of the cartridge assembly and oriented outwardly with respect to said axis;
(C) A staple driving body attached to the housing so as to move between a retracted position and an extended position, wherein the staple driver engages with the staples of the first staple group in the cartridge, and moves from the retracted position to the extended position. A staple driver comprising a pusher having a plurality of pusher arms for ejecting staples from the cartridge when moved toward the cartridge;
(D) after the staple of the previous group has been emitted from the cartridge, by advancing the cartridge relative to the pusher, the staple group of the next turn in the cartridge, the associated pusher arm in said pusher An indexing mechanism located within the staple housing, disposed for engagement;
(E) an anvil housing having an anvil, wherein the staple housing and the anvil housing are toward and away from the stapling position under control of a housing driver in one of the housings. Mounted in relative movement with respect to each other, and in the stapling position, a tissue fold disposed between the two housings is captured for stapling between the cartridge assembly and the anvil. And
Continuously stapling the tissue fold captured between the cartridge assembly and the anvil with staples from successive biased staple groups in the cartridge assembly without reloading the device. A stapled tissue fold can be formed ,
The cartridge is a cylindrical magazine, and a plurality of biased staple slots of the cylindrical magazine extend through the cartridge assembly and taper at the bottom of the slot to hold the staples therein. Eggplant , equipment.
（ａ）偏倚したステープルスロットの複数の群を有するステープルカートリッジであって、各群中のスロットは該カートリッジの中心軸線のまわりに円形に配列され、前記軸線に関して外側に向かって配向されている、ステープルカートリッジと、
（ｂ）前記スロット内に保持され、前記カートリッジの外面から延びる一対の自由端を有するステープルと、
（ｃ）前記カートリッジの外面に対して積層された複数の組織固定リングとを備え、各リングは、各ステープル群に対して１つのリングが前記カートリッジアセンブリに積層されるように、所与のステープル群中のステープルの自由端を内部に受容するための複数の円形に配列にされた穴を有し、前記ステープル群は外側から内側の方向に積層されたリングの順序で射出される、ステープルカートリッジアセンブリ。 A staple cartridge assembly for use with a stapling device for generating a plurality of stapled tissue folds without the need to reload the device between successive plications, wherein the staple cartridge assembly comprises:
A staple cartridge having a plurality of groups of (a) biasing the staple slots, the slots in each group are arranged in a circle around a central axis of the cartridge are oriented outwardly with respect to said axis, A staple cartridge;
(B) a staple having a pair of free ends held in the slot and extending from an outer surface of the cartridge;
(C) a plurality of tissue anchoring rings stacked against the outer surface of the cartridge, each ring having a given staple such that one ring for each staple group is stacked in the cartridge assembly. Staple cartridge having a plurality of circularly arranged holes for receiving the free ends of the staples in the group therein, the staple group being ejected in the order of rings stacked from the outside to the inside. assembly.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261667376P | 2012-07-02 | 2012-07-02 | |
| US61/667,376 | 2012-07-02 | ||
| PCT/US2013/049125 WO2014008289A2 (en) | 2012-07-02 | 2013-07-02 | Stapler for forming multiple tissue plications |
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| JP2015522350A JP2015522350A (en) | 2015-08-06 |
| JP2015522350A5 JP2015522350A5 (en) | 2016-07-28 |
| JP6235008B2 true JP6235008B2 (en) | 2017-11-22 |
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| JP2015520660A Active JP6235008B2 (en) | 2012-07-02 | 2013-07-02 | Stapling apparatus and staple cartridge assembly |
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| US (2) | US9907553B2 (en) |
| EP (1) | EP2819593B1 (en) |
| JP (1) | JP6235008B2 (en) |
| CN (1) | CN104394779B (en) |
| AU (1) | AU2013286733B2 (en) |
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2013
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- 2013-07-02 WO PCT/US2013/049125 patent/WO2014008289A2/en active Application Filing
- 2013-07-02 JP JP2015520660A patent/JP6235008B2/en active Active
- 2013-07-02 AU AU2013286733A patent/AU2013286733B2/en not_active Ceased
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| AU2013286733A1 (en) | 2014-10-02 |
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| CN104394779A (en) | 2015-03-04 |
| WO2014008289A3 (en) | 2014-02-27 |
| EP2819593B1 (en) | 2017-12-13 |
| US9907553B2 (en) | 2018-03-06 |
| JP2015522350A (en) | 2015-08-06 |
| US20140374465A1 (en) | 2014-12-25 |
| WO2014008289A2 (en) | 2014-01-09 |
| CA2869449A1 (en) | 2014-01-09 |
| AU2013286733B2 (en) | 2017-09-14 |
| CN104394779B (en) | 2017-04-12 |
| EP2819593A2 (en) | 2015-01-07 |
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